Positive Psychology for Acute Coronary Syndrome Patients (PEACE-IV)
6 maja 2020 zaktualizowane przez: Jeff C. Huffman, MD, Massachusetts General Hospital
Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial
This is a randomized controlled pilot trial in approximately 50 acute coronary syndrome patients to determine if a 12 week, telephone-delivered, combined positive psychology-motivational interviewing intervention is feasible and more effective than a motivational interviewing health education program at improving health behaviors and other outcomes.
The investigators hypothesize that the intervention will be associated with better mental and physical health outcomes and better health behavior adherence compared to the motivational interviewing health education program.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
The initial study visit will occur in-person two weeks after discharge from the hospital.
Participants will meet with a member of the study staff (the study "trainer") and complete self-report questionnaires assessing health behavior adherence and mental and physical health.
Then, participants will be randomized to receive the positive psychology + motivational interviewing or the motivational interviewing health education interventions.
A study interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the first exercise.
If the participant is in the positive psychology + motivational interviewing condition, the trainer will explain the rationale for both the positive psychology and goal-setting portions of the program, and will be assigned the first exercise.
Similarly, if the participant is randomized into the motivational interviewing health education program, the interventionist will introduce them to the program and assign the first exercise.
Participants in both groups will then be given an accelerometer, which they will be asked to wear for 7 days to ensure that they are comfortable with the device and that useable data can be obtained from the participant.
Participants in both groups will then complete twelve 30-minute weekly phone sessions with a study trainer.
The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.
Upon the completion of these calls, and again at a final follow-up timepoint at 24 weeks, a blinded member of the study staff will call participants to administer self-report outcome measures.
Participants will also be asked to wear an accelerometer at each of these follow-up timepoints as an objective measure of physical activity, which they will return by mail to the study staff.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
69
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
- Massachusetts General Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Adult patients admitted to Massachusetts General Hospital or Brigham and Women's Hospital inpatient units
- Diagnosis of acute coronary syndrome (using established criteria for myocardial infarction or unstable angina; confirmed via medical record and/or patient's treatment team)
- Age 18 or older
- Suboptimal adherence on MOS-SAS: Score < 15 OR Score = 15 with physical activity < 6
Exclusion Criteria:
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically ill patients in research studies.
- Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator.
- Inability to perform moderate to vigorous physical activity, as defined by an inability to walk without aid of an assistive device such as a walker or cane, OR inability to walk at a steady pace for at least 5 minutes without stopping.
- Inability to communicate in English.
- Inability to participate in physical activity
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Psychologia pozytywna + rozmowa motywacyjna
Uczestnicy będą wykonywać cotygodniowe ćwiczenia z psychologii pozytywnej oraz systematycznie wyznaczać sobie cele związane z aktywnością fizyczną.
Trenerzy będą co tydzień przeglądać ćwiczenia z psychologii pozytywnej przez telefon i będą stosować techniki wywiadów motywacyjnych, aby ułatwić wyznaczanie celów.
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W przypadku części interwencji dotyczącej psychologii pozytywnej, trener badania (a) przejrzy ćwiczenie z psychologii pozytywnej z danego tygodnia, (b) omówi uzasadnienie ćwiczenia z psychologii pozytywnej z następnego tygodnia poprzez przegląd podręcznika psychologii pozytywnej oraz (c) przydziel ćwiczenie z psychologii pozytywnej na następny tydzień.
W części rozmowy motywacyjnej uczestnicy (a) przejrzą swój cel dotyczący aktywności fizycznej z poprzedniego tygodnia, (b) omówią techniki poprawy aktywności fizycznej oraz (c) ustalą cel dotyczący aktywności fizycznej na następny tydzień.
Trenerzy będą stosować techniki rozmów motywacyjnych, aby ułatwić wyznaczanie celów.
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Aktywny komparator: Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer.
During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week.
Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
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Each week, participants will learn about a different health behavior topic related to cardiac health.
They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.
The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Feasibility of the PP-MI Based Health Behavior Intervention
Ramy czasowe: 24 weeks
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Feasibility will be measured by examining the number of completed exercises.
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24 weeks
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Acceptability of the PP-MI Exercises: Utility Score
Ramy czasowe: Weeks 1-12
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Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful).
Weekly utility ratings were averaged to provide an overall utility score of the exercises.
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Weeks 1-12
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Acceptability of the PP-MI Exercises: Ease Score
Ramy czasowe: Weeks 1-12
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Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy).
Weekly ratings were averaged to provide an overall ease of the exercises.
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Weeks 1-12
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Minutes of Moderate to Vigorous Physical Activity (Actigraph)
Ramy czasowe: MVPA at 12 weeks and 24 weeks
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ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness.
In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.
In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.
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MVPA at 12 weeks and 24 weeks
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Change in Medication Adherence
Ramy czasowe: Change in score from Baseline to 12 weeks, 24 weeks
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Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks.
Minimum: 0, Maximum:100.
Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks.
Higher score indicates greater levels of medication adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Dietary Adherence
Ramy czasowe: Change in score from Baseline to 12 weeks, 24 weeks
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Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.
Minimum= 0; Maximum= 216.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate lower levels of dietary adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Positive Affect
Ramy czasowe: Change in score from Baseline to 12 weeks, 24 weeks
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The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect.
(Range: 10-50).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of positive affect.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Trait Optimism
Ramy czasowe: Change in score from baseline to 12 week, 24 week
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Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.
(Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of optimism.
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Change in score from baseline to 12 week, 24 week
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Change in State Optimism
Ramy czasowe: Change of score from Baseline to 12 weeks, 24 weeks
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Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation.
Minimum:7, Maximum:35.
The higher number indicates a greater level of optimism.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 weeks, 24 weeks
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Changes in HADS-A Scores
Ramy czasowe: Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.
(Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of anxiety.
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Change in score from Baseline to 12 week, 24 week
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Change in HADS-D Scores
Ramy czasowe: Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range:
0-21).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate worse outcome (i.e.
greater levels of depression).
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Change in score from Baseline to 12 week, 24 week
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Change in Physical Function
Ramy czasowe: Change of score from Baseline to 12 week, 24 week
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Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity.
Minimum: 0, Maximum: 58.2.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of functional capacity.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Physical)
Ramy czasowe: Change of score from Baseline to 12 week, 24 week
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Mental)
Ramy czasowe: Change of score from baseline to 12 and 24 weeks.
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from baseline to 12 and 24 weeks.
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Change in Adherence to Health Behaviors
Ramy czasowe: Change of score from Baseline to 12 week, 24 week
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Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score.
(Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate better adherence to health behaviors.
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Change of score from Baseline to 12 week, 24 week
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Change in Cardiac Symptoms
Ramy czasowe: Change of score from Baseline to 12 week, 24 week
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Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients.
Minimum: 0, Maximum: 30.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of cardiac symptoms.
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Change of score from Baseline to 12 week, 24 week
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Change in Physical Activity
Ramy czasowe: Change of score from Baseline to 12 week, 24 week
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Measured by the self-report International Physical Activity Questionnaire (IPAQ).
The measure asseses the types of intensity of physical activity that people do as part of their daily lives.
All activities are converted to multiples of resting energy expenditure (MET) minutes per week.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 week, 24 week
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Change in Perceived Stress
Ramy czasowe: Change of score from Baseline to 12 week, 24 week
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Measured by the Perceived Stress Scale (PSS-4) measure.
Minimum: 0, Maximum: 16.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress.
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Change of score from Baseline to 12 week, 24 week
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Jeff Huffman, MD, Massachusetts General Hospital
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 maja 2017
Zakończenie podstawowe (Rzeczywisty)
10 lipca 2018
Ukończenie studiów (Rzeczywisty)
26 listopada 2018
Daty rejestracji na studia
Pierwszy przesłany
6 kwietnia 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
17 kwietnia 2017
Pierwszy wysłany (Rzeczywisty)
20 kwietnia 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 maja 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 maja 2020
Ostatnia weryfikacja
1 maja 2020
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- R01HL113272 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .